None listed
Conditions
Brief summary
This study focuses on patients who were diagnosed positive or had a recurrence for TCC over the past 5 years and who are undergoing a schedule of investigative cystoscopies and treatment for the possible (further) recurrence of urinary tract transitional cell cancer. Eligible consenting patients will provide a freshly voided mid-stream urine sample prior to cystoscopy (as per normal clinical practice). Part of this sample will be used for local cytology and other analysis as deemed clinically appropriate. The remainder will be used for dipstick analysis of specific gravity, presence of red and white blood cells and infection. Aliquots will be taken for uRNA-2, NMP22 BladerChek, NMP22 ELISA and urine cytology. This is a non interventional study. No deviation from patient care is undertaken. Results of the study tests are not communicated to the clinician and are therefore have no effect on patient treatment.
Interventions
A routine urine sample taken for local cytology and / or urinalysis at the clinic immediately prior to an investigative cystoscopy for the monitoring of recurrent bladder cancer. An aliquot of this sample is taken for the purposes of this study. Sample is aliquotted and preserved in stabilisation liquids and sent to lab for analysis. Aliquots will be used for urine cytology, NMP22 ELISA, NMP22 BladderChek and uRNA-2. Patient medical information is obtained. No deviation from standard care is un
A routine urine sample taken for local cytology and / or urinalysis at the clinic immediately prior to an investigative cystoscopy for the monitoring of recurrent bladder cancer. An aliquot of this sample is taken for the purposes of this study. Sample is aliquotted and preserved in stabilisation liquids and sent to lab for analysis. Aliquots will be used for urine cytology, NMP22 ELISA, NMP22 BladderChek and uRNA-2. Patient medical information is obtained. No deviation from standard care is undertaken. Patients may be asked for additional samples if they present for further scheduled cystoscopies within the duration of the study. No additional visits to clinic will be required as a result of participation in the study. Output of the study will be at the completion of patient recruitment and data cleaning and analysis. 300 patients are required for this study. Recruitment rates are variable but the recruitment window is estimated to terminate in September 2012.
Sponsors
Pacific Edge PTY Ltd.
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Positive primary or recurrence diagnosis for urinary tract TCC within the past 5 years and confirmation by histopathological examination of resected tissue or confirmation by histopathological examination of biopsy tissue 2. Patient is undergoing investigative cystoscopies for the monitoring of recurrence of urinary tract TCC at intervals prescribed by clinical practitioner 3. Patient is able to provide a voided urine sample of the required minimum volume 4. Patient is able to give written informed consent 5. Patient is able and willing to comply with study requirements
Exclusion criteria
1. Prior genitourinary manipulation in the 14 days before urine collection, 2. Current symptoms specific to urinary tract infection as evident on preliminary examination 3. Current or known history of urinary tract inflammatory disorder, 4. Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, 5. Recent history of pyelonephritis 6. Total cystectomy of the bladder
Outcome results
None listed